Aseptic Coupling Devices

ABSTRACT

An aseptic coupling arrangement can include a first coupling device and a second aseptic coupling device. In one embodiment, the first and second coupling devices are substantially similar, each having a main body defining a front face and a fluid passageway therethrough. A first connecting feature disposed on the main body of each coupling device may be provided for aligning and coupling the aseptic devices together. Each coupling device may also include a sealing member received in the main body and a membrane removably coupled to the main body front face to cover the sealing member. The first aseptic coupling device may also include a rotatable protective cover that is removably attached to the main body and connected to the membrane. In one embodiment, the removal of the protective covers away from two coupled main bodies, in a direction parallel to the front faces, causes removal of the membranes.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 16/387,829, filed on Apr. 18, 2019, which is a continuationapplication of U.S. application Ser. No. 15/144,380, filed May 2, 2016(now U.S. Pat. No. 10,307,583), which is a divisional application ofU.S. application Ser. No. 13/800,630, filed on Mar. 13, 2013 (now U.S.Pat. No. 9,364,653), which claims priority to U.S. Application Ser. No.61/639,121, filed Apr. 27, 2012. The entire contents of all of the aboveidentified patent applications are hereby incorporated by reference.

BACKGROUND

Aseptic coupling devices can be used to connect two or more sterilizedfluid pathways. For example, aseptic coupling devices can be used tocouple a fluid pathway from a first piece of processing equipment orcontainer to a fluid pathway from a second piece of processing equipmentor container to establish a sterile pathway for fluid transfertherebetween. Typical aseptic coupling devices require a “dry-to-dry” or“dry connection” that is created using one or more pathway clampingdevices placed upstream of the aseptic coupling devices so that theaseptic coupling devices are kept free of fluid while the connectionbetween the aseptic coupling devices is made. Once the sterileconnection between the aseptic coupling devices is made, the clampingdevices are removed to allow fluid to flow through the aseptic couplingdevices.

SUMMARY

This disclosure relates to aseptic coupling devices and arrangements. Inaccordance with the disclosure, a first aseptic coupling device forcoupling to a second aseptic coupling device is disclosed. In oneembodiment, the first aseptic coupling device has a first main bodydefining a front face and a first fluid passage therethrough. A firstconnecting feature disposed on the main body may be provided that isconfigured to couple the first aseptic device to the second asepticcoupling device. The first aseptic coupling device may also include afirst sealing member received at least partially within the first mainbody, and a first membrane removably coupled to the front face of thefirst main body to cover the first sealing member.

The first aseptic coupling device may also include a first protectivecover removably connected to the main body and connected to the firstmembrane. The first protective cover may be configured to be rotatablefrom a closed position, in which the protective cover covers at least aportion of the membrane covering the main body front face, to an openposition in which the membrane covering the front face of the main bodyis exposed. In one embodiment, the removal of the first protective coveraway from the main body in a direction parallel to the front face causesthe first membrane to be removed from the front face.

An aseptic coupling arrangement is also disclosed that includes both thefirst and second aseptic coupling device, wherein the second asepticcoupling device has the same features as previously described for thefirst aseptic coupling device. For example, the second aseptic couplingdevice may include a second main body, a second connecting feature, asecond sealing member, a second membrane, and a second protective cover.In one embodiment, the protective covers of each device are configuredto be attached to each other such that the membranes of the first andsecond aseptic coupling devices can be removed from their respectivefront faces at the same time in simultaneous or near simultaneousfashion.

In one embodiment, the first and second connecting features each includea first connector and a second connector, wherein the second connectorof the first aseptic coupling device can be received within the firstconnector of the second aseptic coupling device, and wherein the secondconnector of the second aseptic coupling device can be received withinthe first connector of the first aseptic coupling device. In oneembodiment, the first and second connecting members of the first andsecond aseptic coupling devices are configured to align the front facesof each main body such that the front faces are parallel to each other.In one embodiment, the first and second aseptic coupling devices have asubstantially similar construction.

A method for forming a sterile connection is also disclosed. One stepincludes providing first and second aseptic coupling devices wherein thefirst aseptic coupling device has a construction that is substantiallysimilar to the second aseptic coupling device. The method may alsoinclude the steps of rotating a protective cover of the first asepticcoupling device to an open position to expose a membrane covering afront face of the first aseptic coupling device and rotating aprotective cover of the second aseptic coupling device to an openposition to expose a membrane covering a front face of the secondaseptic coupling device. Additional steps in the method are connectingthe first aseptic coupling device to the second aseptic coupling deviceand connecting the protective cover of the first aseptic coupling deviceto the protective cover of the second aseptic coupling device. A finalstep in the method may be removing membranes from the front faces of thefirst and second coupling devices by detaching the connected protectivecovers from the first and second coupling devices in a directionparallel to the front faces of each main body. Once the membranes havebeen removed in this fashion, a sterile fluid passageway through thefirst and second coupling devices is provided.

DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments are described with referenceto the following figures, which are not necessarily drawn to scale,wherein like reference numerals refer to like parts throughout thevarious views unless otherwise specified.

FIG. 1 is a schematic view of an example system including first andsecond pieces of processing equipment and an aseptic coupling deviceforming a sterile connection therebetween.

FIG. 2 is a perspective view of an example aseptic coupling arrangementin a pre-coupled state.

FIG. 3 is a side view of the aseptic coupling arrangement of FIG. 2.

FIG. 4 is a cross-sectional side view of the aseptic couplingarrangement of FIG. 2.

FIG. 4A is a schematic side view of a membrane suitable for use with theaseptic coupling arrangement of FIG. 2.

FIG. 4B is a cross-sectional side view of the aseptic couplingarrangement of FIG. 2, with cover portions removed from the main bodiesof the coupling arrangement.

FIG. 5 is a cross-sectional view of the aseptic coupling arrangement ofFIG. 2 in a coupled state.

FIG. 6 is a perspective view of the aseptic coupling arrangement of FIG.2 in an uncoupled state.

FIG. 7 is a front perspective view of a main body and protective coverof one coupling device of the aseptic coupling arrangement of FIG. 2,with the protective cover being in an open position.

FIG. 8 is a rear perspective view of the main body and protective coverof the coupling device of FIG. 7, with the protective cover being in anopen position.

FIG. 9 is a front perspective view of the main body and protective coverof the coupling device of FIG. 7, with the protective cover being in aclosed position.

FIG. 10 is a first side view of the main body and protective cover ofthe coupling device of FIG. 7, with the protective cover being in aclosed position.

FIG. 11 is a first side view of the main body and protective cover ofthe coupling device of FIG. 7, with the protective cover being in anopen position.

FIG. 12 is a second side view of the main body and protective cover ofthe coupling device of FIG. 7, with the protective cover being in aclosed position.

FIG. 13 is a second side view of the main body and protective cover ofthe coupling device of FIG. 7, with the protective cover being in anopen position.

FIG. 14 is a front view of the main body and protective cover of thecoupling device of FIG. 7, with the protective cover being in a closedposition.

FIG. 15 is a rear view of the main body and protective cover of thecoupling device of FIG. 7, with the protective cover being in a closedposition.

FIG. 16 is a front view of the main body and protective cover of thecoupling device of FIG. 7, with the protective cover being in an openposition.

FIG. 17 is a rear view of the main body and protective cover of thecoupling device of FIG. 7, with the protective cover being in an openposition.

FIG. 18 is a first side cross-sectional view of the main body andprotective cover of the coupling device of FIG. 7, with the protectivecover being in a closed position.

FIG. 19 is a first side cross-sectional view of the main body andprotective cover of the coupling device of FIG. 7, with the protectivecover being in an open position.

FIG. 20 is a second side cross-sectional view of the main body andprotective cover of the coupling device of FIG. 7, with the protectivecover being in a closed position.

FIG. 21 is a second side cross-sectional view of the main body andprotective cover of the coupling device of FIG. 7, with the protectivecover being in an open position.

FIG. 22 is a top view of the main body and protective cover of thecoupling device of FIG. 7, with the protective cover being in an openposition.

FIG. 23 is a bottom view of the main body and protective cover of thecoupling device of FIG. 7, with the protective cover being in an openposition.

FIG. 24 is a front perspective view of the main body shown in FIG. 7.

FIG. 25 is a front view of the main body shown in FIG. 7.

FIG. 25A is a cross-sectional view of a portion of the main body of FIG.7, taken along section line 25A-25A shown in FIG. 25.

FIG. 26 is a cross-sectional side view of the main body shown in FIG. 7.

FIG. 27 is a front perspective view of the protective cover shown inFIG. 7.

FIG. 28 is a rear perspective view of the protective cover shown in FIG.7.

FIG. 29 is a side view of the protective cover shown in FIG. 7.

FIG. 30 is a front view of the protective cover shown in FIG. 7.

FIG. 31 is a perspective view of a sealing member receivable in the mainbody shown in FIG. 7.

FIG. 32 is a front view of the sealing member shown in FIG. 31.

FIG. 33 is a side view of the sealing member shown in FIG. 31.

FIG. 34 is a cross-sectional side view of the sealing member shown inFIG. 31.

FIG. 35 is a side view of a second embodiment of a main body suitablefor use in the coupling device shown in FIG. 7.

FIG. 36 is a side view of a third embodiment of a main body suitable foruse in the coupling device shown in FIG. 7.

FIG. 37 is a side view of a fourth embodiment of a main body suitablefor use in the coupling device shown in FIG. 7.

FIG. 38 is a first side view of the main body and protective cover ofthe coupling device of FIG. 7, with the protective cover being in anopen position, wherein the main body further includes an optional visualindicator.

FIG. 38A is an enlarged side view of the coupling device and visualindicator shown in FIG. 38.

FIG. 39 is a perspective view of an aseptic coupling arrangement formedfrom two of the coupling devices of FIG. 7 having the optional visualindicator.

FIG. 40 is a side view of the coupling arrangement shown in FIG. 39.

FIG. 41 is a flow diagram of a method of creating an aseptic coupling ofa first coupling device and a second coupling device.

DETAILED DESCRIPTION

Various embodiments will be described in detail with reference to thedrawings, wherein like reference numerals represent like parts andassemblies throughout the several views. Reference to variousembodiments does not limit the scope of the claims attached hereto.Additionally, any examples set forth in this specification are notintended to be limiting and merely set forth some of the many possibleembodiments for the appended claims.

As used herein, the term “sterilize” means a process of freeing, to aspecified degree, a surface or volume from microorganisms. In exampleembodiments, the sterility of various components can be achieved usingone or more sterilization techniques, including gamma irradiation,E-beam, ethylene oxide (EtO), and/or autoclave technologies.

As used herein, the term “aseptic” refers to any process that maintainsa sterilized surface or volume.

As used herein, the term “fluid” means any substance that can be made toflow including, but is not limited to, liquids, gases, granular orpowdered solids, mixtures or emulsions of two or more fluids,suspensions of solids within liquids or gases, etc.

Referring now to FIG. 1, an example system 10 is shown. System 10includes a first piece of processing equipment 20 and a second piece ofprocessing equipment 30. In example embodiments, equipment 20 and 30 arebioreactors including biomaterial. In other embodiments, equipment 20and 30 can be other apparatuses that require a sterile connectiontherebetween such as, for example, a bioreactor and a media bag or otherreceptacle.

Equipment 20 includes a fluid pathway 22 extending therefrom that isterminated by an aseptic coupling arrangement 50 including a firstaseptic coupling device 100 a. Likewise, equipment 30 includes a fluidpathway 32 extending therefrom that is terminated by a second asepticcoupling device 100 b of the aseptic coupling arrangement 50. In exampleembodiments, aseptic coupling devices 100 a and 100 b are substantiallysimilar (e.g., identical except for possibly differences interminations). In example embodiments, the environment within pathways22 and 32 and aseptic coupling devices 100 a and 100 a are sterile.

The aseptic coupling arrangement 50 can be placed in an uncoupled state,a pre-coupled state and in a coupled state. FIG. 6 shows the asepticcoupling arrangement 50 in an uncoupled state wherein the couplingdevices 100 a, 100 b are aligned but not yet connected to each other inany way. In the pre-coupled state, as shown in FIGS. 2-4, the devices100 a, 100 b are connected to each other, but a fluid pathway throughthem is blocked by a membrane 400 sealed onto each of the couplingdevices 100 a, 100 b. In the coupled state, as shown in FIG. 5, themembranes 400 are removed and a sterile fluid pathway is establishedbetween equipment 20 and equipment 30. Once the sterile fluid pathway isestablished, fluid can be transferred from equipment 20 to equipment 30,or vice versa.

In the example embodiments shown, the aseptic coupling devices 100 a and100 b are of similar construction. As such, coupling devices 100 a and100 b may be individually referred to as coupling device 100 herein forease of reference. However, it is noted that each aseptic couplingdevice 100 a, 100 b may be provided with different features than theother, as desired.

As shown in a fully assembled state in FIGS. 7-23, coupling device 100includes a main body 102, and a sealing member 200 disposed within themain body 102. Coupling device 100 also includes a protective cover 300removably connected to the main body 102. The cover 300 is rotatablewith respect to the main body 102 between a closed position (see e.g.FIG. 9) and an open position (see e.g. FIG. 2). A membrane 400 is alsoprovided on coupling device 100 that is removably connected to the mainbody 102 at a first end 402 and also connected to the protective cover300 at a second end 404. Each of these features of coupling device 100is described in further detail below.

As most easily viewed at FIGS. 24-26, the main body 102 has a front face104 and a rear face 106 onto which a conduit connection 108 is formed. Afluid passageway 110 within the main body 102 is defined between a firstopen end 112 and a second open end 114. As most easily seen at FIG. 26,the main body 102 defines a recess 116, having a first internal diameterD.sub.1, for receiving a sealing member 200, discussed later. Conduitconnection 108 defines a second internal diameter D.sub.2 along fluidpassageway 110. The second diameter D.sub.2 is provided at a dimensionthat is generally about the same as the nominal internal diameter of theconduit to which the main body 102 is designed for connection. Forexample, D.sub.2 can be designed to provide a ¼ inch diameter flow. At alocation where the first and second internal diameters D.sub.1, D.sub.2adjoin, a seal seat 118 is formed at a depth L.sub.1 from the front face104 for supporting and forming a seal with sealing member 200.

As stated previously, the second end 114 of the fluid passageway 110 isconfigured to be connected to a fluid pathway via the conduit connection108. In the example shown, the conduit connection is barbed to form anHB type connection so that the main body 102 can be connected to a fluidpathway (e.g., 22) such as a tube or hose of a specified diameter, forexample ⅛ inch, ¼ inch, and ⅜ inch. Other larger sizes are alsopossible, such as ½ inch, ⅝ inch, ¾ inch, 1 inch, etc. In the embodimentshown at FIGS. 2-26, conduit connection 108 is sized for a ¼ inchconnection. FIG. 35 shows a conduit connection 108′ provided on a mainbody 102′ that is sized for a ⅛ inch connection. Instead of a barbedconnection feature, many other types of connections known in the art maybe provided, for example, sanitary, flared, threaded, quick connect, andcompression type connections. To further illustrate such options, FIG.36 shows a sanitary conduit connection 108″ provided on a main body 102″while FIG. 37 shows a quick-connect type conduit connection 108′″provided on a main body 102″. Conduit connection 108 may also beprovided as a female type connection. In yet other examples, theconnection can be a quick-connect type body with a latch and valving.This allows the body to be coupled to a male insert mounted to theconduit during fluid flow. Upon completion, removal of the male from thequick-connect type body causes the valve to close, thereby creating avalved disconnect.

Still referring to FIG. 24-26, the front face 104 of the main body 102further includes a plurality of stand-off protrusions 124 configured toengage a corresponding plurality of stand-off protrusions 124 on thefront face 104 of another main body 102 under certain conditions. Forexample, at least some of the opposing stand-off protrusions 124 willcome into contact with each other when the main bodies 102 are overcompressed together and/or when a side load is imparted on one or bothof the main bodies 102. In the pre-coupled and coupled positions,opposing protrusions 124 are not ordinarily in contact with each otherwhen no external forces are present, thus allowing the seals 200 to befully engaged and compressed against each other due to the connectors132, 134 (discussed later) on the main bodies 102. As such, stand-offprotrusions 124 help to stabilize the connection to reduce thepossibility of side load induced leakage. One skilled in the art, uponlearning of the disclosed concepts presented herein, will appreciatethat more or fewer stand-off protrusions may be provided on each face toensure the same stated functionality.

The front face 104 of the main body 102 may be provided with surfacelocations 120, 122 to allow for the first end 402 of the membrane 400 tobe attached to the front face 104. In examples, the membrane 400 iscoupled to the front face 104 completely around and beyond the firstopen end 112 of the main body 102 at attachment locations 120, 122. Theattachment locations 120,122 allow membrane 104 to extend beyond theopening in the open end 112 so that as membrane 400 is removed, thesterility of open end 112 is maintained. In one embodiment, the surfacelocations 120, 122 are provided with an adhesive 148 to which themembrane 400 is adhered in a folded over arrangement, as shownschematically in FIG. 4A. In one embodiment, the adhesive 148 can beprovided on the membrane 400 which can be subsequently attached tosurface locations 120, 122. In one embodiment, the membrane 400 is heatwelded to the front face 104. In such an embodiment, surface locations120, 122 are not necessarily required.

As shown, the main body 102 is also provided with a notch 126 forengaging with a corresponding latch 306 on the protective cover 300 whenthe protective cover 300 is rotated into the closed position. Otherarrangements for retaining the protective cover 300 in the closedposition are possible. For example, a latch could be provided on themain body 102 and a notch could be provided on the protective cover 300.

Main body 102 is also provided with a pair of hinge members 128, 130 forretaining a corresponding hinge member 304 on the protective cover 300.As shown, hinge members 128, 130 each have an opening 128 a, 130 a intowhich the hinge member 304 can be pressed for a snap fit. Once snappedinto position, the protective cover 300 can rotate with respect to themain body 102 between the open and closed positions. When the protectivecover 300 has been rotated into the open position, the protective cover300 may be pulled downward (i.e. in a direction D parallel to the frontface 104 of the main body 102 as shown at FIGS. 3-4) and snapped out ofthe hinge members 128, 130 to separate the protective cover 300 from themain body 102. It is noted that, instead of the shown configuration,that hinge members 128, 130 may have a male type configuration while thehinge member 304 may have a female configuration. Additionally, fewer ormore hinge members 128, 130, and 304 may be provided.

In order to enable the main body 102 of a first coupling device 100 a tobe connected to the main body 102 of a second coupling device 100 b, afirst connector 132 and a second connector 134 may be provided. In theembodiment shown, first and second connectors 132, 134 are located onopposite sides of the front face 104 of the main body 102. Theconnectors 132, 134 are designed to be engaged with each other and toensure proper alignment of the front faces 104 of the coupling devices100 a, 100 b. Accordingly, when the first coupling device 100 a isoriented with its front face 104 facing the front face 104 of the secondcoupling device 100 b, the second connector 134 of the first couplingdevice 100 a will engage with the first connector 132 of the secondcoupling device 100 b. Likewise, the second connector 134 of the secondcoupling device 100 b will engage with the first connector 132 of thefirst coupling device. Many types of connectors that perform thefunctions of engagement and alignment may be utilized without departingfrom the concepts presented herein.

In the exemplary embodiment shown, the first connector 132 includes anextension 136 with a curved main portion 136 a and side portions 136 bthat together form a channel 138. The channel 138 defines an interiorvolume 140 within which a latch member 142 is provided. As can be bestseen at FIG. 25A, the latch member 142 has an extension 142 a, a rampedsurface 142 b, and a locking surface 142 c. The ramped surface 142 b, asoriented in the embodiment shown, faces towards the curved main portion136 a of the extension 136.

The second connector 134 includes an extension 144 located on theopposite side of the front face 104 from which the first connectorextends. The extension 144 has a curved main portion 144 a and sideedges 144 b. The curved main portion 144 a of the second connector 134is configured to be received within the interior volume 140 of thechannel 138 of the first connector 132. Proper alignment between twomating main bodies 102 is ensured by the side portions 136 b of thefirst connector extension 136 which surround and guide the side edges144 b of the second connector extension 144.

The extension 144 of the second connector 134 also has a latch engagingsurface 144 c for engaging with the locking surface 142 c of the latchmember 142 such that two mated main bodies 102 cannot be separated onceplaced in the pre-coupled state. Accordingly, as the front faces 104 ofeach coupling device 100 a, 100 b are pressed towards each other, thelatch members 142 engage the latch engaging surfaces 144 c to secure thedevices 100 a, 100 b together in a pre-coupled state. This action alsoprovides an audible clicking sound to provide an indication to a userthat the pre-coupled state has been achieved. In this state, the sealingmembers 200 of each device 100 a, 100 b are compressed against eachother with membranes 400 therebetween.

Other arrangements of the latching member and the latch engaging surfaceare possible. For example, the latch engaging surface 144 c could beprovided on the first connector 132 with the latch member 142 beingprovided on the second connector 134. Alternatively, the first couplingdevice could be provided with first and second connectors that aresubstantially similar to each other wherein the second coupling deviceis also provided with substantially similar first and second connectorsconfigured to engage with those on the first coupling device. However,it should be understood that the disclosed embodiments allow for theproduction of a single main body for both coupling devices 100 a, 100 b.Such a configuration can allow for better economies of scale, lessinventory management, improved system flexibility, and less requiredtraining. Connectors other than latches may also be utilized.

With reference to FIGS. 31-34, sealing member 200 is shown in furtherdetail. In the embodiment shown, the sealing member 200 has a lengthL.sub.2 extending between a first face 202 and a second face 204 that isslightly greater than the length L.sub.1 of the recess 116 of the mainbody 102. The greater length of the sealing member 200 ensures that thesealing member 200 makes sufficient contact with a corresponding sealingmember 200 in a second main body 102 to form an aseptic seal. Sealingmember 200 also has a central opening 206 having an internal diameterD.sub.3 that is about the same dimension as the diameter D.sub.2 of theconduit connection 108. Sealing member 200 also has an external diameterD.sub.4 that is about the same dimension as the diameter D.sub.1 of therecess 116 in the main body 102. In one embodiment, external diameterD.sub.4 is greater than length L.sub.2. In one embodiment, externaldiameter D.sub.4 is from about 1.25 times to about 1.75 times greater,for example about 1.5 times greater, than length L.sub.2.

Sealing member 200 also has a sidewall S that has a reduced thickness atthe midpoint of the sidewall S. On the exterior portion, the sidewall Shas a reduced thickness defined by an outside radius r.sub.o. On theinterior portion, the sidewall S has a reduced thickness defined by aninside radius r.sub.i. In one embodiment, the dimension of the insideradius r.sub.i is greater than the dimension of the outside radiusr.sub.o. In one embodiment, the dimension of the inside radius r.sub.iis equal to or greater than twice the dimension of the outside radiusr.sub.o, for example about 2.4 times larger. In one embodiment, theinside radius r.sub.i is between about 0.2 inch to about 0.3 inch, forexample about 0.26 inch. In one embodiment, the outside radius r.sub.ois between about 0.1 inch to about 0.25 inch, for example about 0.11inch.

Where the inside radius r.sub.i is greater than the outside radiusr.sub.o, the seal structure enhances the axial compression performanceof the sealing member 200 (compressed between the seal seat 118 at firstface 202 and another sealing member 200 at second face 204) whileensuring that flow through the sealing member 200 is not restricted bythe unintended formation of an inwardly extending bulge undercompression. Because the inside radius r.sub.i is larger than theexterior radius r.sub.o, a compressive force on the seal against faces202, 204 will tend to cause the sidewall S to deflect outwardly awayfrom the central opening 206 of the seal 200. Accordingly, the internalflow path through the seal 200 is not unnecessarily constricted bycompression of the seals 200. Such a structure is especially usefulwhere a mechanical sensor may be inserted through the central opening206 of the seal. The described seal structure also provides for enhancedsealing when the system is pressurized.

With reference to FIGS. 27-30, the protective cover 300 is shown infurther detail. The protective cover 300 serves two primary functions.The first function is to protect the membrane 400, the sealing member200, and the front face 104 of the main body 102 when the couplingdevice 100 is in an uncoupled or isolated state. To serve this purpose,the protective cover 300 is placed in the closed position so that atleast a portion of the membrane 400 is covered by the cover 300. Thesecond function is to provide a means for removing membranes 400 afterthe first and second coupling devices 100 a, 100 b have been placed inthe pre-coupled state. To serve this purpose, the protective cover 300is placed in the open position. In the open position, the portion of themembrane 400 covering the main body front face 104 is exposed.

In the embodiment shown, the protective cover 300 has a main body 302extending between a first side 302 a, a second side 302 b and between afirst end 302 c and a second end 302 d. The main body 302 also defines afirst surface 310 and a second surface 312. The first surface 310 facesthe front face 104 of the main body 102 of the coupling device 100 whenthe protective cover 300 is in the closed position. Accordingly, thefirst surface 310 operates to protect the membrane 400, the sealingmember 200, and the front face 104 of the main body 102. Additionally,when the cover 300 is in the closed position, the first surface 310slightly compresses sealing member 200 which relieves pressure thatsealing member 200 would otherwise exert on membrane 400. Thiscompressed state of sealing member 200 is most easily seen at FIGS. 18and 20. FIGS. 19 and 21 show the sealing member 200 in a more relaxedstate even though membrane 400 still covers the sealing member 200.

The second surface 312 of the protective cover 300 is provided to allowfor the second end 204 of the membrane 400 to be attached to theprotective cover 300. In one embodiment, second surface 312 is providedwith an adhesive 148 to which the membrane is adhered. In oneembodiment, the adhesive 148 can be provided on the membrane 400 whichcan be subsequently attached to second surface 312. See FIG. 4A for anexample arrangement of membrane 400 with respect to the second surface312. In one embodiment, the membrane 400 is heat welded to the secondsurface 312. The connection of the membrane 400 to the protective cover300 is sufficiently secure to retain the membrane 400 onto theprotective cover 300 when removing the membrane 400 from the front face104 of the coupling device main body 102. This result is largelyaccomplished by the rolled over arrangement of the membrane 400 withrespect to the main body 102. This arrangement allows for membrane 400to be peeled off the front face 104 in a direction D with significantlyless force than would be required to shear the second end 404 of themembrane 400 from the protective cover second surface. It is also notedthat a strength difference may be acquired by using specific adhesivesand/or by manipulating the relative surface areas of the portions of themembrane that are actually attached to the cover 300 and main body 102.

As stated previously, the main body 302 at the second end 302 d isprovided with a hinge member 304 that can be received in the hingemembers 128, 130 of the main body 102. At the first end 302 c of themain body 302, a handle member 314 is provided. Handle member 314 is foroperating the protective cover 300 between the open and closedpositions, and for use as a gripping member when pulling the protectivecover 300 away from the main body 102 of the coupling device 100. Asshown, handle member 314 includes surface features 314 a, such aschannels or ribs, for enhancing the ability of a user to grip and exertforce on the handle member 314.

Each protective cover 300 is also provided with a locking tab 306 and acorresponding recess 308. As stated previously, the locking tab 306 canbe snapped into or engaged with notch 126 of the coupling device mainbody 102. Additionally, the locking tab 306 can be snapped into therecess 308 of another protective cover 300 when two coupling devices 100a, 100 b are placed in the pre-coupled position and when each protectivecover 300 is in the open position, as shown in FIGS. 2-4. The attachmentof the protective covers 300 to each other is enabled because, when inthe open position, the face 302 e of the cover body 302 at the locationof tab 306 and recess 308 is generally in the same plane P as the mainbody front face 104. Once in this attached position, the protectivecovers 300 may be pulled in a downward direction D that is parallel tothe front faces 104 via handle portions 314 to remove membranes 400 fromthe main body front faces 104 of the coupling devices 100 a, 100 b. Asthe membranes 400 are removed, the second faces 204 of the sealingmembers 200 come into contact with each other and form an aseptic seal.In this condition, the coupling devices 100 a, 100 b are now in thecoupled state.

Because the protective covers 300 are locked together, this arrangementensures that the membranes 400 will roll onto themselves and detach fromthe front faces 104 in a simultaneous or a near simultaneous fashion.However, it is noted that the membranes 400 can be removed in sequentialfashion as well if the protective covers 300 are not secured together,although sterility may be compromised.

Referring to FIGS. 38 to 40, an embodiment of a coupling device 100including an optional visual indicator 500 is shown. The optional visualindicator 500 is for providing a visual indication that the couplingdevices 100 a, 100 b have not been fully engaged into the pre-coupledposition. Such a feature is beneficial in that an operator can verifythat the coupling devices 100 a, 100 b are properly connected to eachother prior to removing the membranes 400.

As best seen at FIGS. 38 and 38A, visual indicator 500 includes a firstvisual indicator 500 a and a second visual indicator 500 b, both ofwhich are provided on the outer surface of the second connecting feature134. As shown, each visual indicator 500 has a height h.sub.1 and awidth w.sub.1. In one embodiment, height h.sub.1 is from about 0.1 inchto about 0.2 inch, for example about 0.14 inch. In one embodiment, widthw.sub.1 is from about 0.01 inch to about 0.1 inch, for example about0.06 inch.

As most easily seen at FIG. 38A, each visual indicator 500 can also beset back from the rear face 106 of the main body 102 by a distancex.sub.1. If the visual indicator 500 is provided such that it extendsall of the way to the rear face 106, a portion of the visual indicator500 may be visible when viewed from an angle. As such, setting back thevisual indicator 500 from the rear face 106 helps to ensure that no partof the visual indicator 500 is visible when the coupling devices 100 a,100 b are placed in the pre-coupled position, even when viewed from anangle. In one embodiment, distance x.sub.1 is from about 0.01 inch toabout 0.1 inch, for example about 0.10 inch.

Because the second connecting feature 134 is entirely received withinthe first connecting feature 132 in the pre-coupled state, the visualindicators 500 a, 500 b are entirely obscured from view when thecoupling devices 100 a, 100 b are successfully placed in the pre-coupledstate. However, as can be seen at FIGS. 39-40, the indicators 500 a, 500b are exposed when the coupling devices 100 a, 100 b are not fullyengaged, even when not engaged by only a small distance. For example,the visual indicators 500 a, 500 b are easily visible even when thecoupling devices 100 a, 100 b are separated by only 0.04 inch, as is thecase in FIGS. 39-40.

Referring now to FIG. 41, an example method 1000 for connecting asepticcoupling device 100 a to aseptic coupling device 100 b is shown.

First, at operation 1002, a first aseptic coupling device 100 a and asubstantially similar second aseptic coupling device 100 a are provided.In one embodiment, each aseptic coupling device includes a main body 102having an internal fluid passageway 110 and first and second connectingfeatures 132, 134. A sealing member 200 at least partially receivedwithin the main body 102 is also included as is a removable membrane 400attached to the main body 102 and covering the internal fluid passageway110. Each aseptic coupling device also includes a removable cover 300rotatably and removably attached to the main body 102 that is alsoattached to the removable membrane 400. In one embodiment, step 1002includes providing first and second aseptic coupling devices 100 a, 100b that are not identical to each other.

Second, at operation 1004, protective covers 300 of each asepticcoupling device are moved to an open position.

At operation 1006, the first and second aseptic coupling devices 100 a,100 b are aligned with each other in an uncoupled state and thenconnected to each other to form a pre-coupled state, for example viaconnecting features 132, 134.

At operation 1008, the protective covers 300 are attached to each otherwhile at operation 1010, the membranes 400 of each coupling device 100a, 100 b are removed by detaching the protective covers 300 from thecoupling devices 100 a, 100 b. As noted above, the removal of themembranes 400 allows for the sealing members 200 to engage with eachother resulting in the formation of a sterile connection. It is alsonoted that steps 1008 may be eliminated and step 1010 may includeremoving the membranes one at a time in a sequential fashion althoughsterility may be compromised.

In example embodiments, the aseptic coupling devices and theirrespective covers are made of a polymeric material. For example, in oneembodiment, the aseptic coupling devices are made of polycarbonate andthe sealing members used therein are made of a silicone rubber. Othermaterials can be used.

In some embodiments, membrane 400 is autoclavable and gamma stable forsterilization. In various embodiments, membrane 400 is a compositedesign that consists of two components: 1 tag and 1 vent. The tag is alaminate including: a polyethylene terephthalate (PET) film,polyethylene (PE) foam, aluminum foil, and a sealing layer. The foamand/or foil may or may not exist in the final configuration. The sealinglayer allows the tag to be bonded or welded to polycarbonate connectors(e.g., aseptic coupling devices 100 a and 100 b).

The vent is an expanded poly(tetrafluoroethylene) (ePTFE) membrane thatwill be bonded or welded onto the tag. Membrane 400 is located over thecenter of the flow area of aseptic coupling devices 100 a and 100 b,respectively, when the tags and vents are bonded or welded toconnectors. The vent allows air and steam to flow into the system 10during sterilization. The pore size of membrane 400 is such thatmembrane 400 filters out microorganisms larger than 0.2 microns.

In another embodiment, membrane 400 is a polyethersulfone (PES) andpolyester laminate membrane. This membrane is hydrophobic andbreathable. The pore size is such that microorganisms larger than 0.2microns are filtered out. When bonded, the polycarbonate melts into thepolyester fibers, so that the PES acts as the filter, and the polyesteracts as the structure.

In other embodiments, membrane 400 is a Tyvek membrane that is coated onone side to allow membrane 400 to be bonded to polycarbonate connectors(e.g., aseptic coupling devices 100 a and 100 b). Tyvek is breathable innature, so there is no need for an additional vent. Tyvek is a non-wovenpolyethylene membrane.

The various embodiments described above are provided by way ofillustration only and should not be construed to limit the claimsattached hereto. Those skilled in the art will readily recognize variousmodifications and changes that may be made without following the exampleembodiments and applications illustrated and described herein, andwithout departing from the true spirit and scope of the disclosure.

What is claimed is:
 1. A method for forming a sterile connection, themethod comprising: a. providing first and second aseptic couplingdevices, the first aseptic coupling device having a first main body, thesecond aseptic coupling device having a second main body; b. moving afirst protective cover of the first aseptic coupling device to an openposition to expose a first membrane covering at least a portion of afront face of the first aseptic coupling device; c. moving a secondprotective cover of the second aseptic coupling device to an openposition to expose a second membrane covering at least a portion offront face of the second aseptic coupling device; d. connecting thefirst aseptic coupling device to the second aseptic coupling device; e.connecting the first protective cover of the first aseptic couplingdevice to the second protective cover of the second aseptic couplingdevice; and f. removing the first and second membranes from the frontfaces of the first and second coupling devices by detaching theconnected first and second protective covers from the first and secondcoupling device main bodies in a direction parallel to the front facesto provide a sterile fluid passageway through the first and secondcoupling devices.
 2. The method of claim 1, wherein the first and secondmembranes of the first and second aseptic coupling devices are removedfrom each main body front face simultaneously.
 3. The method of claim 1,wherein the first and second aseptic coupling devices are configured toalign the front faces of each main body such that the front faces areparallel to each other.
 4. The method of claim 3, wherein the first andsecond aseptic coupling devices have a substantially similarconstruction.
 5. The method of claim 1, wherein the first and secondaseptic coupling devices are each provided with a visual indicator thatis visible when the coupling devices are in an uncoupled state, and thatis obscured from view when the first and second connecting features ofthe first coupling device are fully engaged with the respective firstand second connecting features of the second coupling device.
 6. Themethod of claim 5, wherein the visual indicator is set back from a rearface of the main body of each of the first and second coupling devices.7. The method of claim 1, wherein the step of connecting the firstaseptic coupling device to the second aseptic coupling device includesengaging a first connector of the first aseptic coupling device with asecond connector of the second aseptic coupling device
 8. The method ofclaim 7, wherein the step of connecting the first aseptic couplingdevice to the second aseptic coupling device further includes engaging athird connector of the first aseptic coupling device with a fourthconnector of the second aseptic coupling device, wherein the first andthird connectors are identically configured and the second and fourthconnectors are identically configured.
 9. A method for forming a sterileconnection, the method comprising: a. providing first and second asepticcoupling devices, the first aseptic coupling device having a first mainbody, the second aseptic coupling device having a second main body; b.moving a first protective cover of the first aseptic coupling device toan open position to expose a first membrane covering at least a portionof a front face of the first aseptic coupling device; c. moving a secondprotective cover of the second aseptic coupling device to an openposition to expose a second membrane covering at least a portion offront face of the second aseptic coupling device; d. connecting thefirst aseptic coupling device to the second aseptic coupling device; ande. simultaneously removing the first and second membranes from the frontfaces of the first and second coupling devices by detaching the firstand second protective covers from the first and second coupling devicemain bodies to provide a sterile fluid passageway through the first andsecond coupling devices.
 10. The method of claim 9, further includingthe step of connecting the first protective cover to the secondprotective cover prior to the step of detaching the first and secondcovers from the first and second coupling device main bodies.
 11. Themethod of claim 9, wherein the step of detaching the first and secondprotective covers includes detaching the first and second covers in adirection parallel to the front faces of the first and second asepticcoupling devices.
 12. The method of claim 9, wherein the first andsecond aseptic coupling devices are configured to align the front facesof each main body such that the front faces are parallel to each other.13. The method of claim 9, wherein the first and second aseptic couplingdevices have a substantially similar construction.
 14. The method ofclaim 9, wherein the first and second aseptic coupling devices are eachprovided with a visual indicator that is visible when the couplingdevices are in an uncoupled state, and that is obscured from view whenthe first and second connecting features of the first coupling deviceare fully engaged with the respective first and second connectingfeatures of the second coupling device.
 15. The method of claim 14,wherein the visual indicator is set back from a rear face of the mainbody of each of the first and second coupling devices.
 16. The method ofclaim 9, wherein the step of connecting the first aseptic couplingdevice to the second aseptic coupling device includes engaging a firstconnector of the first aseptic coupling device with a second connectorof the second aseptic coupling device
 17. The method of claim 16,wherein the step of connecting the first aseptic coupling device to thesecond aseptic coupling device further includes engaging a thirdconnector of the first aseptic coupling device with a fourth connectorof the second aseptic coupling device, wherein the first and thirdconnectors are identically configured and the second and fourthconnectors are identically configured.
 18. A method for forming asterile connection, the method comprising: a. providing similarlyconfigured first and second aseptic coupling devices, the first asepticcoupling device having a first main body, the second aseptic couplingdevice having a second main body; b. moving a first protective cover ofthe first aseptic coupling device to an open position to expose a firstmembrane covering at least a portion of a front face of the firstaseptic coupling device; c. moving a second protective cover of thesecond aseptic coupling device to an open position to expose a secondmembrane covering at least a portion of front face of the second asepticcoupling device; d. connecting the first aseptic coupling device to thesecond aseptic coupling device by engaging a first connector of thefirst aseptic coupling device with a second connector of the secondaseptic coupling device; and e. connecting the first protective cover tothe second protective cover prior to the step of detaching the first andsecond covers from the first and second coupling device main bodies; f.simultaneously removing the first and second membranes from the frontfaces of the first and second coupling devices by detaching the firstand second protective covers from the first and second coupling devicemain bodies in a direction parallel to the front faces to provide asterile fluid passageway through the first and second coupling devices.19. The method of claim 18, wherein the step of engaging a firstconnector to a second connector includes the second connector beingformed as a female connector that receives the first connector formed asa male connector.
 20. The method of claim 18, wherein the step ofconnecting the first aseptic coupling device to the second asepticcoupling device further includes engaging a third connector of the firstaseptic coupling device with a fourth connector of the second asepticcoupling device, wherein the first and third connectors are identicallyconfigured and the second and fourth connectors are identicallyconfigured.